The PICCOLETO IX PHENO Study
ConditionCoronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS
About this trial
To investigate whether pre-procedural OCT-derived de novo coronary lesion phenotype (lipid-rich, fibrotic, calcific; and ACS mechanisms such as plaque rupture/erosion/calcified nodule) is associated with clinical outcomes after DCB angioplasty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic coronary syndrome or acute coronary syndrome diagnosis (per ESC guidelines).
De novo obstructive CAD: ≥50% left main stenosis, or any stenosis ≥70%, or FFR <0.80 in any other major epicardial vessel, or MLA deemed ischemic at intravascular imaging.
OCT assessment of the target segment phenotype prior to lesion preparation and DCB angioplasty.
Successful DCB angioplasty according to DCB ARC criteria.
Disqualifiers
Previous revascularization of the target segment with stent.
Hybrid DCB-DES PCI with DCB-treated segment <20 mm and/or lacking complete OCT assessment of the DCB-treated segment and/or bailout stenting.
Lack of at least 6 months of clinical follow up.
PCI of chronic total occlusion.
Trial population
Adult patients with chronic coronary syndrome or acute coronary syndrome who underwent drug-coated balloon angioplasty for de novo obstructive coronary artery disease with preprocedural optical coherence tomography assessment of the target segment.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Clinically-driven Target Lesion Revascularization (TLR)
Any repeat revascularization (percutaneous or surgical) of the target lesion performed for recurrent symptoms or objective evidence of ischemia attributable to the target lesion.
Time frame
12 monthsSecondary outcomes
1
Device-Oriented Composite Endpoint (DOCE)
Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization.
Time frame
12 months2
Target Vessel Revascularization (TVR)
Any repeat revascularization (percutaneous or surgical) of the target vessel.
Time frame
12 months3
All-cause Mortality
Death from any cause during the study follow-up period.
Time frame
12 months4
Cardiac Death
Death attributed to cardiovascular causes, including death from unknown cause.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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